1. Field of Invention
This invention relates generally to the treatment of male impotence, and more particularly, to a technique for this purpose which is applied to a male organ whose tissues lack sufficient plasticity to achieve and maintain an erection, the technique acting to restore the plasticity of these tissues and thereby overcome impotence.
2. Status of Prior Art
Male impotence is an abnormal condition in which an individual is unable to achieve and maintain an adequate penile erection for coitus. Because male impotence is now widespread, it has attracted considerable medical and scientific interest directed toward finding an effective treatment therefor.
While male impotence is usually imputed to the aging process, it is by no means a condition confined to older men. Thus it is not unusual to find an individual of no more than 20 years of age exhibiting the early symptoms of male impotence.
Male impotence has often been attributed to psychological factors, such as stress, depression, financial worries and a failing marriage. But in our clinical experience with patients who suffer from male impotence, psychological factors account for only a small percentage of male impotence cases.
Various diseases, such as diabetes and multiple sclerosis may give rise to male impotence, and male impotence can also be an adverse side effect of some prescription drugs or result from substance abuse. However, in our clinical studies, these do not account for a high percentage of male impotence cases.
In these studies we have found that the most significant factor accounting for male impotence is the impaired physical fitness of the male organ, per se, separate and apart from all other considerations. Thus a subject who is free of disease and of psychological disorders, and who seemingly is in superb physical condition, may nevertheless be unable to perform sexually.
We have found that the physical fitness of a male organ depends on the plasticity of its tissues. Our studies show that the central core lesion in male impotence is a loss of plasticity so that the tissues of the organ are unable to stretch and expand to permit the organ to change from an initially flaccid state to an erectile state. It is only when the tissues of the male organ possess a normal degree of plasticity that the organ is then capable of achieving and maintaining the erectile state necessary for coitus and ejaculation. A loss of plasticity of the penile tissues of the corpus cavernosum renders the male organ incapable of expanding and contracting.
The loss of plasticity is not an overnight phenomenon, but is a gradual process which is insidious. As an individual experiences a gradual loss of plasticity, he then tend to reduce his sexual activity, for he finds it increasingly difficult to attain an erection. The resultant inactivity of the male organ gives rise to a further loss of plasticity until a point is reached where the individual becomes effectively impotent and is unable to function sexually despite the fact that he is otherwise healthy and in good physical condition.
The degree to which the tissues of a male organ possess or lack plasticity is easily determined. With normal plasticity, the organ feels rubbery and elastic, whereas when the organ loses plasticity, it becomes softer and mushy, sponge-like or flabby.
The male organ is composed of three columns of erectile tissue, two dorsolateral (corpa cavernosa) and one medial (corpus spongiosum) which contain the urethra and expands at the end to form the glans penis. The tissues support blood vessels that perform complex hemodynamic processes. For an erection to occur and be maintained, the arterioles, the veins as well as valves in the veins, must work in conjunction with changes taking place in the penile tissues. A loss of plasticity adversely affects the dynamics of flow in the arterioles and veins and impairs the ability of the valves in the venous system to operate properly.
During erection, the caverns of the corpus cavernosum fill with blood and dilate. This action stretches the smooth muscles lining the walls of these caverns and the connective tissue disposed therebetween. The two erectile cylinders then increase dramatically in size. When the erection thereafter subsides, the elastic recoil of the walls return the caverns to their normal size.
The ability of a male organ to achieve and maintain an erectile state therefore depends on the plasticity of its tissues, this plasticity determining the fitness of the sexual organ for its intended purpose.
As the ability to maintain an erection diminishes, there is a corresponding decline in the plasticity of the tissues. Both processes feed on each other in a spiraling descent leading to a condition of total impotence.
When male impotence is due to the loss of plasticity of the tissues of the penis, this condition cannot be overcome by the use of vasodilators, such as prostaglandins (Alprostadil). These drugs act to dilate the cavernosal arteries, resulting in an increased arterial inflow velocity. But should the tissues of the penis lack plasticity, the penis may not achieve and maintain an erectile state.
Heretofore, the treatment of male impotence was not calculated to overcome impotence, but to simulate potency by artificial means causing an impotent male organ to assume an erectile state.
To this end, the Lederer U.S. Pat. No. 1,225,341 places an impotent male organ in a vacuum chamber which acts to draw blood into the penis to induce vacuum engorgement. When the penis is in an engorged state it is then erect, this erection being secured by means of an elastic cincture band which acts as a tourniquet to prevent the blood from leaving the penis.
The Osborne U.S. Pat. Nos. 4,378,008, 5,083,556 and 4,856,498 disclose various types of vacuum enhancement devices in which a vacuum chamber is provided with a port into which a flaccid penis is inserted, the vacuum chamber being coupled to a manual pump.
Of greater prior art interest is the Osborne et al. U.S. Pat. No. 5,421,808. This patent discloses a self-contained battery-operated external vacuum device that includes an electric motor coupled to a reciprocating diaphragm pump. Because this vacuum device is electrically-powered, it is more easily regulated and controlled.
A vacuum erection device (VED), whether manually or electrically operated, does not cure impotence, but simply acts to simulate potency. Thus when this device by means of a negative pressure draws blood into the penis so that it is engorged, this imitates a normal erection. However to maintain this synthetic erection, the penis must be girded to prevent the blood from escaping.
While an individual who simulates an erection by means of a vacuum erection device can perform coitus, the engorged penis is effectively a dildo which is a poor substitute for a normally erect penis capable of ejaculating. Hence sexual activity made possible by a vacuum erection device in many respects falls short of natural coitus.